The University of Texas Medical Branch at Galveston will be allowed to resume some drug research using state prison convicts after convincing federal investigators that procedural safety lapses will be corrected and submitting to increased federal oversight, university officials announced recently.
In late September, the federal Office of Human Research Protections ordered the university to stop the prison-based research projects and hundreds of other projects involving humans after alleging that federal rules had not been followed. The agency questioned whether some prisoners had been properly warned of the risks, whether some experiments were impermissibly risky and whether, in some cases, the potential benefits may have been overstated and the risks understated to prospective participants.
The federal office is a division of the U.S. Department of Health and Human Services. It approves and monitors all medical research involving humans.
In all, university officials said more than 300 ongoing projects were affected by the suspension order -- including 26 separate projects using prisoners, most involving treatments for HIV and AIDS, with some for hepatitis C and cancer.
Despite the order, university officials said recently that none of the projects involving convicts had been suspended because UT Medical Branch doctors determined it was in the best medical interest of the 99 convicts in the 26 prison-based programs to continue treatments uninterrupted. Federal officials had allowed that exemption.
Under a revised federal directive, the university will create two review boards instead of one to scrutinize projects before they start -- each with 20 members, instead of 37 in all. Advocates for prisoners will be named to both panels, officials said.
Before research projects involving prisoners can resume, the panels must review and reapprove each one, and the federal office must ratify their decisions -- a process that university officials said will take weeks, maybe even months. All other research projects involving humans will be reviewed and approved as well.
Of the suspended projects to be reapproved, university officials said they expect 97 can be back in operation within a week, while 207 others may take up to two months to review.
University officials will be required to submit quarterly reports documenting actions taken to correct deficiencies and ensure compliance with federal laws.